HEAT Trial (HER2 Antibody Therapy With Lutetium-177)

ConditionsHER2 Gene Mutation Advanced Solid Tumors

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorRadiopharm Theranostics, Ltd

About this trial

This is a first-in-human, Phase 0/1, open-label study of177Lu-RAD202 consisting of an Imaging Period with 177Lu-RAD202im(imaging dose) and a Treatment Period with 177Lu-RAD202tr(treatment dose) to determine the recommended dose(s) for future exploration of 177Lu-RAD202 in participants with HER2 expressing advanced solid tumours.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years and older.

Written, voluntary, informed consent of the participants must be obtained in compliance with institutional, regional, and federal guidelines.

Participants with histologically or cytologically confirmed, HER2 positive or HER2-low, advanced solid tumours that are relapsed/refractory, locally advanced not amenable to curative-intent therapy, or metastatic, with documented disease progression during or after their most recent line of anti-cancer therapy. Participants must be refractory to or intolerant of standard of care therapy or have no standard of care therapy available that is likely to provide clinical benefit.

Must have at least 1 measurable target lesion according to RECIST version 1.1.

Disqualifiers

Participants who have any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or nonmelanoma skin cancer. Participants with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with the study Sponsor, if it is determined not to put the participant at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.

Participants who have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time-point imaging procedures, etc.

Residual toxicity Grade ≥ 2 from previously administered therapy (except for alopecia).

Creatinine clearance or Body Surface Area (BSA) adjusted Estimated glomerular filtration rate (eGFR) (calculated using any clinically validated formula, preferably Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), or measured) < 60 mL/min

Trial design

Design model

Single group

Treatments tested in this trial

177Lu-RAD202
Drug
177Lu-RAD202 administered at Imaging (im) and Treatment (tr) doses

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: 177Lu-RAD202Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Time Activity Curves (TACs)

Percent of the injected activity vs time for selected organs and tumors

Time frame

72 hours

Radiation dosimetry of Lu177-RAD202im

Absorbed radiation doses of 177Lu-RAD202im in critical organs (e.g., kidneys, bone marrow)

Time frame

72 hours

Safety and tolerability of a single dose of 177Lu-RAD202tr

The properties, incidence, nature and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) per Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time frame

6 weeks

Recommended dose(s) of 177Lu-RAD202tr for future exploration

Incidence of dose-limiting toxicities (DLTs) during the first 6 weeks following 177Lu-RAD202tr injection cycle of treatment

Time frame

6 weeks

Secondary outcomes

Safety and tolerability of 177Lu-RAD202im

The properties, incidence, nature and severity of AEs and SAEs per Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time frame

6 weeks

Recommended dose(s) of 177Lu-RAD202im for future exploration

Incidence of dose-limiting toxicities (DLTs) in the first 2 weeks following 177Lu-RAD202im injection

Time frame

2 weeks

Preliminary antitumor activity of 177Lu-RAD202tr

Objective response rates (ORR) as assessed by RECIST v1.1

Time frame

Up to 30 weeks

Radiation dosimetry of 177Lu-RAD202tr

Absorbed radiation doses of 177Lu-RAD202tr in critical organs (e.g., kidneys, bone marrow)

Time frame

72 hours

Other outcomes

Level of agreement between 177Lu-RAD202im and standard of care imaging

Standard of care imaging may include but is not limited to 18F-FDG-PET, CT-scan and/or 99mTc-MDP-bone

Time frame

Up to 30 weeks

Effect of 177Lu-RAD202im and 177Lu-RAD202tr on tumor markers

Circulating tumor DNA

Time frame

Up to 30 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Radiopharm Theranostics, Ltd

Lead sponsor

Source ClinicalTrials.gov

Apply now